The University of Birmingham’s Clinical Trials Units currently partner with industry, for medical devices and for drugs, to answer research questions, where the questions are driven by the clinical investigators in the hope of answering questions that change clinical practice and generate academic publications.
In our current partnerships with industry, the industry’s involvement is entirely to provide us with the drug or the medical device, and sometimes a small amount of funding to help us deliver the trial.
The results in the trials are delivered to good regulatory standards. But the results couldn’t be used, for example, for a drug to be taken forward for licencing. So if we want the drug, therefore, to have a change in its licencing label – or for a device, a way to be delivered in the clinic, to be fully licenced – then these data are probably not at the right regulatory standard to do this.
The aim of the trial will then be to answer a research question, working with clinical investigators, in patient areas of major medical need, but where the data that is generated by the clinical trial can contribute to a change in the label of a drug – so how it’s licenced to be used – or the regulatory approval of a device. And this will accelerate the use of drugs and devices in clinical practice.
One of the advantages of a University-industry partnership is that we will be able to use our expertise in delivering what are called platform trials. These are trials where we can work with multiple industry partners and be able to answer questions for an individual device or drug for an industry partner, but in a platform trial.
This will be a much more efficient way to be able to answer the questions quickly, particularly when the patient population is quite small, so running lots of individual trials would be impractical and take a very long time. It’s another way that we’ll be able to accelerate the process.
Currently we have two UKCRC accredited clinical trials at the University with extensive experience in delivering trials from early phase trials – these are safety trials for drugs and devices – right through to large randomised clinical trials, which are practice-changing trials.
Our experience to date with working with industry has been very much more as entirely investigator driven. But we’ve been working over the last year to change our operating procedures and to better understand the needs of industry. And now we’ve put together a framework, as well as a team, who will be able to better meet the needs of industry, and therefore better meet the needs of patients.
When the BPMC ITH is fully up and running, this will be a one- stop shop, a place where industry partners will be able to come and work with the University of Birmingham and the Clinical Trials Units to deliver trials to the regulatory standards required for licencing.
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